<b>Background:</b> When chemotherapy is indicated in patients with early breast cancer, regimens that contain anthracyclines and taxanes are established standard treatments. Gemcitabine has shown promising effects on the response and prognosis in patients with metastatic breast cancer. The SUCCESS-A trial (NCT02181101) examined the addition of gemcitabine to a standard chemotherapy regimen in high-risk early breast cancer patients. <b>Methods:</b> A total of 3754 patients with at least one of the following characteristics were randomly assigned to one of the two treatment arms: nodal positivity, tumor grade 3, age ≤ 35 years, tumor larger than 2 cm, or negative hormone receptor status. The treatment arms received either three cycles of 5-fluorouracil, epirubicin, and cyclophosphamide, followed by three cycles of docetaxel (FEC → Doc); or three cycles of FEC followed by three cycles of docetaxel and gemcitabine (FEC → Doc/Gem). The primary study aim was disease-free survival (DFS), and the main secondary objectives were overall survival (OS) and safety. <b>Results:</b> No differences were observed in the 5-year DFS or OS between FEC → Doc and FEC → Doc/Gem. The hazard ratio was 0.93 (95% CI, 0.78 to 1.12; P = 0.47) for DFS and 0.94 (95% CI, 0.74 to 1.19; P = 0.60) for OS. For patients treated with FEC → Doc and FEC → Doc/Gem, the 5-year probabilities of DFS were 86.6% and 87.2%, and the 5-year probabilities of OS were 92.8% and 92.5%, respectively. <b>Conclusion:</b> Adding gemcitabine to a standard chemotherapy does not improve the outcomes in patients with high-risk early breast cancer and should therefore not be included in the adjuvant treatment setting. <b>Trial registration:</b> Clinicaltrials.gov NCT02181101 and EU Clinical Trials Register EudraCT 2005–000490–21. Registered September 2005.

中文翻译：

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早期乳腺癌：在辅助化疗中加入吉西他滨无益处

<b>背景：</b>当早期乳腺癌患者需要化疗时，含有蒽环类和紫杉烷类的方案是标准治疗方案。吉西他滨对转移性乳腺癌患者的反应和预后显示出有希望的效果。SUCCESS-A 试验 (NCT02181101) 检查了在高危早期乳腺癌患者中将吉西他滨添加到标准化疗方案中的情况。<b>方法：</b> 共有 3754 名至少具有以下特征之一的患者被随机分配到两个治疗组之一：淋巴结阳性、肿瘤 3 级、年龄 ≤ 35 岁、肿瘤大于 2 cm ，或负激素受体状态。治疗组接受了三个周期的 5-氟尿嘧啶、表柔比星和环磷酰胺，随后是三个周期的多西紫杉醇（FEC → Doc）；或三个周期的 FEC，然后是三个周期的多西他赛和吉西他滨（FEC → Doc/Gem）。主要研究目标是无病生存期（DFS），主要次要目标是总生存期（OS）和安全性。<b>结果：</b> FEC → Doc 和 FEC → Doc/Gem 之间的 5 年 DFS 或 OS 没有观察到差异。DFS 的风险比为 0.93（95% CI，0.78 至 1.12；P=0.47），OS 的风险比为 0.94（95% CI，0.74 至 1.19；P=0.60）。对于接受 FEC → Doc 和 FEC → Doc/Gem 治疗的患者，DFS 的 5 年概率分别为 86.6% 和 87.2%，OS 的 5 年概率分别为 92.8% 和 92.5%。<b>结论：</b> 将吉西他滨添加到标准化疗中并不能改善高危早期乳腺癌患者的预后，因此不应将其包括在辅助治疗环境中。<b>试验注册：</b> Clinicaltrials.gov NCT02181101 和欧盟临床试验注册 EudraCT 2005-000490-21。2005 年 9 月注册。